A trial of selumetinib and docetaxel for non small cell lung cancer (SELECT-1)

Cancer type:

Lung cancer

Non small cell lung cancer

Status:

Results

Phase:

Phase 3

This trial was for people whose non small cell lung cancer had grown into surrounding tissues or spread elsewhere in the body. And whose lung cancer cells had a change (mutation Open a glossary item ) to a gene called KRAS.

More about this trial

Cancer that has grown into surrounding tissues or spread to another part of the body is called locally advanced or advanced cancer.

One of the usual treatments for advanced non small lung cancer (NSCLC) is a chemotherapy drug called docetaxel. You might have this on its own or alongside other chemotherapy drugs. But lung cancer is difficult to treat and it can continue to grow despite treatment. So researchers are looking for ways to improve treatment.

In this trial, they looked at a drug called selumetinib. It is a type of targeted cancer drug called a cancer growth blocker. It works by targeting a protein called MEK Open a glossary item . This stops signals that cancer cells use to divide and grow.

The researchers thought that having selumetinib with docetaxel might improve treatment for people whose lung cancer cells have a change to the KRAS gene.

In this trial, some people had docetaxel and selumetinib. And some had docetaxel and a dummy drug (placebo Open a glossary item ).

The aims of the trial were to:

find out which treatment worked best
learn more about the side effects.

Summary of results

The trial team found that adding selumetinib to docetaxel did not improve treatment for people with advanced non small cell lung cancer with a change in the KRAS gene.

505 people took part in this trial. Everyone had at least one treatment for advanced cancer. They were put into 1 of the following treatment groups at random.

251 had docetaxel and selumetinib
254 had docetaxel and a dummy drug

SELECT-1 Diagram

The trial team looked at the average length of time people lived without signs of their cancer getting worse. This is called progression free survival.

They found this was:

3.9 months in people who had docetaxel and selumetinib
2.4 months in people who had docetaxel and the dummy drug

They also looked at how long people lived for. This is called overall survival. On average, they found this was:

8.7 months in people who had docetaxel and selumetinib
7.9 months in people who had docetaxel and the dummy drug

People who had docetaxel and selumetinib had more problems with:

diarrhoea
skin rash
swelling of the hands and feet (peripheral oedema)
weakness or lack of energy
shortness of breath

70 people who had docetaxel and selumetinib needed to have their dose reduced due to side effects compared with 16 who had docetaxel and the dummy drug.

The trial team concluded that in people with advanced NSCLC with a change to the KRAS gene, selumetinib and docetaxel did not work any better than docetaxel on its own.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.